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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1141-4567 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).
Secondary Objectives:
To assess the effects of SC doses of alirocumab on:
Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - Alirocumab | Experimental | Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alirocumab | Drug | Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment | baseline and at 12 days after last dose of alirocumab |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipids turnover parameters measured in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL) | baseline and at 12 days after last dose of alirocumab | |
| Change in post-heparin hepatic lipase and lipoprotein lipase activities |
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Inclusion criteria:
Generally healthy; LDL-C level in serum or plasma ≥ 100 mg/dL and < 190 mg/dL at Screening.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840001 | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27986651 | Result | Reyes-Soffer G, Pavlyha M, Ngai C, Thomas T, Holleran S, Ramakrishnan R, Karmally W, Nandakumar R, Fontanez N, Obunike J, Marcovina SM, Lichtenstein AH, Matthan NR, Matta J, Maroccia M, Becue F, Poitiers F, Swanson B, Cowan L, Sasiela WJ, Surks HK, Ginsberg HN. Effects of PCSK9 Inhibition With Alirocumab on Lipoprotein Metabolism in Healthy Humans. Circulation. 2017 Jan 24;135(4):352-362. doi: 10.1161/CIRCULATIONAHA.116.025253. Epub 2016 Dec 16. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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Single-sequence crossover
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| Placebo | Drug | Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
|
| baseline and at 2 days after last dose of alirocumab |
| Change in lipids and apolipoproteins in plasma lipids panel | baseline and at 2 days and at 11 days after last dose of alirocumab |
| Assessment of Lipoprotein particle size profiles | baseline and at 2 days and at 11 days after last dose of alirocumab |
| Assessment of serum concentrations of PCSK9 | baseline and up to 2 weeks after last dose of alirocumab |
| Assessment of safety parameters (clinical laboratory, ECG, vital signs) | up to 10 weeks after last dose of alirocumab |
| Assessment of the serum concentration of alirocumab | baseline and up to 2 weeks after last dose of alirocumab |
| Assessment of the serum concentration of anti-alirocumab antibodies | baseline and up to 10 weeks after last dose of alirocumab |
| D009750 |
| Nutritional and Metabolic Diseases |